A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

A Phase 3, Multi-Center, Placebo- and Active-Controlled, Randomized, Double-Blind, 12-Week Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients With High TG and Low HDL-C

A Phase 3 Study to Evaluate the Efficacy and Safety of K-877 in Chinese Patients with High TG and Low HDL-C

Study Overview

• Status: Recruiting
• Conditions: Hyperlipidemia
• Intervention / Treatment: Drug: K-877 0.1 mg tablet; Drug: Placebo tablet; Drug: Placebo capsule; Drug: K-877 0.1 mg tablet; Drug: Placebo tablet; Drug: Fenofibrate 200 mg capsule

• Study Type: Interventional
• Enrollment (Anticipated): 350
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Keisuke Kunitomi; Phone Number: 81-3-3279-7454; Email: ctrdinfo@kowa.co.jp

Study Locations

• China
  • Anhui, China, 232000
    • Recruiting
    • Huainan First People's Hospital
  • Beijing, China, 100730
    • Not yet recruiting
    • Beijing Hospital
  • Beijing, China, 100029
    • Not yet recruiting
    • Beijing Anzhen Hospital, Capital Medical University
  • Beijing, China, 100730
    • Not yet recruiting
    • Beijing Tongren Hospital, Capital Medical University
  • Beijing, China, 101200
    • Not yet recruiting
    • Beijing Pinggu Hospital
  • Chengdu, China, 610066
    • Recruiting
    • Chengdu Xinhua Hospital
  • Fujian, China, 350005
    • Recruiting
    • The First Affiliated Hospital of Fujian Medical University
  • Guangdong, China, 100032
    • Not yet recruiting
    • Peking Union Medical College Hospital
  • Guangdong, China, 510080
    • Not yet recruiting
    • The First Affiliated Hospital, Sun Yat-sen University
  • Guangdong, China, 510120
    • Not yet recruiting
    • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
  • Guangxi, China, 530021
    • Not yet recruiting
    • The people's hospital of Guangxi Zhuang Autonomous Region
  • Hainan, China, 570311
    • Not yet recruiting
    • Hainan General Hospital
  • Hebei, China, 050000
    • Recruiting
    • The Second Hospital of Hebei Medical University
  • Helongjiang, China, 150001
    • Recruiting
    • The First Affiliated Hospital Of Harbin Medical University
  • Hubei, China, 430022
    • Recruiting
    • Union Hospital, Tongji Medical College of Huazhong University of Science & Technology
  • Hubei, China, 430030
    • Recruiting
    • Tongji Hospital, Tongji Medical College of HUST
  • Hubei, China, 710068
    • Recruiting
    • Shaanxi provincial people's hospital
  • Hunan, China, 410013
    • Not yet recruiting
    • The Third Xiangya Hospital of Central South University
  • Hunan, China, 410015
    • Recruiting
    • The Third Hospital of Changsha
  • Jiangsu, China, 211100
    • Not yet recruiting
    • Nanjing Jiangning Hospital
  • Jiangsu, China, 211100
    • Not yet recruiting
    • Sir Run Run Hospital Nanjing Medical Universtiy
  • Jiangsu, China, 212001
    • Recruiting
    • Affiliated Hospital of Jiangsu University
  • Jiangxi, China, 330006
    • Not yet recruiting
    • Jiangxi Provincial People's Hospital
  • Jiangxi, China, 330006
    • Recruiting
    • The first affiliated Hospital of Nanchang University
  • Jiangxi, China, 330008
    • Not yet recruiting
    • The First Hospital of Nanchang
  • Jiangxi, China, 332000
    • Recruiting
    • Jiu Jiang No. 1 People's Hospital
  • Jiangxi, China, 337055
    • Recruiting
    • Pingxiang People's Hospital
  • Jilin, China, 330006
    • Not yet recruiting
    • China-Japan Union Hospital of Jilin University
  • Shanghai, China, 200336
    • Not yet recruiting
    • Shanghai Tongren Hospital
  • Sichuan, China, 618000
    • Not yet recruiting
    • People's Hospital Of DeYang City
  • Tianjin, China, 300121
    • Recruiting
    • Tianjin Union Medical Center
  • Zhejiang, China, 310015
    • Not yet recruiting
    • The Affiliated Hospital of Hangzhou Normal University
  • Zhejiang, China, 325000
    • Recruiting
    • People's Hospital of Wenzhou City

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Subjects are eligible to be included in the study only if all of the following criteria apply:

1. Ability to understand and comply with study procedures and give written informed consent
2. Following the diet and lifestyle recommendations at least 12 weeks prior to the treatment period
3. Males or post-menopausal females
4. Aged ≥18 years at the time of informed consent
5. Fasting serum TG levels ≥200 mg/dL (≥2.26 mmol/L) and ≤500 mg/dL (5.65 mmol/L) at screening
6. Serum HDL-C <50 mg/dL (<1.30 mmol/L) if male or <55 mg/dL (<1.42 mmol/L) if female at screening.

Exclusion Criteria:

Subjects are excluded from the study if any of the following criteria apply:

1. Current or planned use of any lipid-altering medications other than the study drugs, statins, or ezetimibe during the study.

   i. Subjects currently on statins or ezetimibe must be at high risk for atherosclerotic CV diseases, and the dose(s) must be stable for at least 4 weeks prior to screening

   ii. For subjects currently on lipid-altering medications other than statins or ezetimibe, at least 4-week washout period (or for subjects currently on probucol at least 8 week washout period) will be required prior to the first fasting blood sampling at Screening Visit

2. Type 1 diabetes mellitus or poorly controlled Type 2 diabetes mellitus defined by HbA1c (NGSP level) ≥8.0% at screening
3. Uncontrolled hypertension defined by seated systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg at screening
4. Uncontrolled thyroid disorder
5. Creatinine ≥1.5 mg/dL at screening
6. Severe hepatic disorder defined as cirrhosis of Child-Pugh class B or C, or AST or ALT >2 × ULN at screening
7. History of pancreatitis
8. Gallbladder disorder, history of cholelithiasis, primary biliary cirrhosis, or history of disease or surgery that may affect the absorption, distribution, metabolism and excretion of drugs or the metabolism of bile salts
9. Unexplained creatine kinase (CK) >5 × ULN at screening
10. Myocardial infraction or stroke (including transient ischemic attack) within 3 months prior to the informed consent
11. New York Heart Association Class III or IV heart failure
12. History of malignancy within 5 years
13. Participation in another clinical study at the time of informed consent or administration of an investigational drug other than placebo within 16 weeks prior to the informed consent for this study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: K-877 0.1 mg BID; K-877 0.1 mg tablet twice daily, Placebo tablet twice daily, Placebo capsule once daily	Drug: K-877 0.1 mg tablet; K-877 0.1 mg tablet x 2 twice daily; Other Names: Pemafibrate; Drug: Placebo tablet; Placebo tablet x 2 twice daily; Other Names: Placebo tablet (matching K-877); Drug: Placebo capsule; Placebo capsule once daily; Other Names: Placebo capsule (matching fenofibrate); Drug: K-877 0.1 mg tablet; K-877 0.1 mg tablet twice daily; Other Names: Pemafibrate; Drug: Placebo tablet; Placebo tablet twice daily; Other Names: Placebo tablet (matching K-877)
EXPERIMENTAL: K-877 0.2 mg BID; K-877 0.1 mg tablet x 2 twice daily, Placebo capsule once daily	Drug: K-877 0.1 mg tablet; K-877 0.1 mg tablet x 2 twice daily; Other Names: Pemafibrate; Drug: Placebo capsule; Placebo capsule once daily; Other Names: Placebo capsule (matching fenofibrate); Drug: K-877 0.1 mg tablet; K-877 0.1 mg tablet twice daily; Other Names: Pemafibrate
ACTIVE_COMPARATOR: Fenofibrate 200 mg QD; Fenofibrate 200 mg capsule once daily, Placebo tablet x 2 twice daily	Drug: Placebo tablet; Placebo tablet x 2 twice daily; Other Names: Placebo tablet (matching K-877); Drug: Placebo tablet; Placebo tablet twice daily; Other Names: Placebo tablet (matching K-877); Drug: Fenofibrate 200 mg capsule; Fenofibrate 200 mg capsule once daily
PLACEBO_COMPARATOR: Placebo; Placcebo tablet x 2 twice daily, Placebo capsule once daily	Drug: Placebo tablet; Placebo tablet x 2 twice daily; Other Names: Placebo tablet (matching K-877); Drug: Placebo capsule; Placebo capsule once daily; Other Names: Placebo capsule (matching fenofibrate); Drug: Placebo tablet; Placebo tablet twice daily; Other Names: Placebo tablet (matching K-877)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percent change in fasting TG versus placebo from baseline to Weeks 8 and 12	From baseline to Weeks 8 and 12
Percent change in fasting TG versus fenofibrate from baseline to Weeks 8 and 12	From baseline to Weeks 8 and 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients who have achieved fasting TG <150 mg/dL at the end of the treatment period	At Week 12
Percent change from baseline to Weeks 8 and 12 in TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated)	From baseline to Weeks 8 and 12
Change from baseline to Weeks 8 and 12 in fasting TG, TC, LDL-C (direct method), LDL-C (Friedewald method), LDL-C (Martin/Hopkins equation), HDL-C (direct method), non-HDL-C (calculated), and remnant cholesterol (calculated)	From baseline to Weeks 8 and 12
Percent change from baseline to the end of the treatment period in Apo A1 and Apo B	From baseline to Week 12
Percent change from baseline to the end of the treatment period in TG/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, LDL-C/HDL-C, LDL-C/Apo B, and Apo B/Apo A1	From baseline to Week 12
The incidence of adverse events and adverse drug reactions after the administration of the study drug	Up to Week 12
Change from baseline to Week 4, 8, and 12 in clinical laboratory tests (chemistry, hematology), vital signs (BP [mmHg], PR [bpm], weight [kg], waist [cm], and BMI [kg/m^2]; each parameter is evaluated individually.), 12-lead ECGs	From baseline to Week 4, 8, and 12
Number and percentage of patients who experience laboratory abnormalities of special interest including, but not limited to ALT, AST, ALP, CK, and, creatinine during the treatment period	Up to Week 12

Collaborators and Investigators

• Sponsor: Kowa Company, Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 17, 2021
• Primary Completion (ANTICIPATED): February 2, 2023
• Study Completion (ANTICIPATED): February 2, 2023

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (ACTUAL): August 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias; Hyperlipidemias; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Hypolipidemic Agents; Lipid Regulating Agents; Fenofibrate
• Other Study ID Numbers: K-877-3.01CH

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No